Actively Recruiting
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Led by Beijing Tongren Hospital · Updated on 2024-04-19
43
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.
CONDITIONS
Official Title
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of extranodal NK/T-cell lymphoma confirmed by pathology and immunohistochemistry
- Relapsed, refractory after initial remission, or newly diagnosed stage III-IV disease
- At least one measurable tumor lesion on PET/CT or CT/MRI
- Expected survival longer than 3 months
- ECOG performance status score of 0 to 2
- Blood tests within 1 week before enrollment meeting: WBC ≥ 3 x 10^9/L, PLT ≥ 75 x 10^9/L, ANC ≥ 1.5 x 10^9/L
- Serum creatinine ≤ 1.5 mg/dL, GFR ≥ 50 ml/min
- Liver enzymes ALT and AST ≤ 3 times upper limit of normal, total bilirubin ≤ 2 times upper limit of normal
- Serum fibrinogen level ≥ 1.0 g/L
- Signed informed consent form
You will not qualify if you...
- Central nervous system involvement or other types of cancer
- Prior treatment with PI3K inhibitors
- Poor performance status with ECOG ≥ 3
- Pregnancy or breastfeeding
- Unwillingness or inability to use effective contraception if of childbearing potential
- Allergy to any study drugs
- Active infections
- History of immunodeficiency including HIV or organ transplantation
- History or suspicion of interstitial or non-infectious pneumonia
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Other serious diseases that may pose safety risks or affect study completion as judged by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Liang Wang
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Liang Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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